Language: BG BG
← Back to results
Recruiting NCT02665923

Gastric Emptying in Neonates and Infants After Formula Feeding

Conditions: Gastric Emptying

Sponsor: Columbia University

trial.available_in: БГ
Overview
Ultrasound imaging will be used to evaluate time for gastric emptying in healthy, fasting newborns, and infants following feeding of clear liquids and/or milk (including breast or formula).
Description
The study involves serial ultrasounds over several visits. Healthy newborns in the Newborn Nursery will be recruited to conduct this study. The study will include a total of 50 healthy newborns who will be given formula feeding of known volume, and then serial ultrasound imaging of gastric antral volume will be performed until gastric emptying. The study originally was designed to perform follow up of these newborns at two later time intervals (between ages 4-6 months, and 9-12 months). The purpose of follow-up is to evaluate whether there are age-related changes in gastric emptying. Due to the pause/suspension of research activity during the pandemic, these follow up studies of the original newborn cohort could not be completed. The protocol is thus revised as follows: The study will recruit 50 4-6 months old and 50 9-12months old infants and perform gastric emptying serial ultrasound to evaluate if there are age-related changes in gastric emptying.
Who can participate
Inclusion criteria for study cohort are pediatric patients from Allen Hospital and Morgan Stanley Children's Hospital of New York Presbyterian Hospital who are receiving feeding by formula 1. healthy full-term (postmenstrual age ≥ 36 weeks) newborns aged 0-5 days or 2. healthy infants (4-6 months old and 9-12 months old) Exclusion criteria are individuals who have 1. newborn history of requirement resuscitation at delivery 2. newborn history of admission to the Neonatal Intensive Care Unit 3. any history of hospital admission 4. history of gastroesophageal reflux or other feeding difficulty 5. receiving any medication known to accelerate or delay gastric emptying, including but not limited to opioid-containing medications and antacids.
Interventions
Gastric ultrasound
OTHER
Locations 1
United States (1)
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York , New York
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Maximum age
12 Months
Healthy volunteers
No
Start date
01.03.2016
Completion date
01.06.2027
Registry ID
NCT02665923
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.